NCT01945515

Brief Summary

  • Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
  • Group 2: Robotic-assisted gait training with sham tDCS (45 min)
  • Duration of treatment: 2 weeks, 5 times a week
  • Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

September 15, 2013

Last Update Submit

December 18, 2016

Conditions

Stroke

Keywords

Stroketranscranial direct current stimulationrobotic rehabilitationgait

Outcome Measures

Primary Outcomes (3)

  • Functional Ambulatory Category (FAC)

    Assesses functional ambulation in patients undergoing physical therapy

    Baseline

  • Functional Ambulatory Category (FAC)

    Assesses functional ambulation in patients undergoing physical therapy

    1 day after treatment

  • Functional Ambulatory Category (FAC)

    Assesses functional ambulation in patients undergoing physical therapy

    4 weeks after treatment

Secondary Outcomes (14)

  • 10-meter walk test

    Baseline

  • 10-meter walk test

    1 day after treatment

  • 10-meter walk test

    4 weeks after treatment

  • 6-min walk test

    Baseline

  • 6-min walk test

    1 day after treatment

  • +9 more secondary outcomes

Study Arms (2)

Robot + anodal tDCS

EXPERIMENTAL

Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min

Device: tDCSDevice: Robotic-assisted gait training

Robot + sham tDCS

SHAM COMPARATOR

Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min

Device: tDCSDevice: Robotic-assisted gait training

Interventions

tDCSDEVICE

tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.

Also known as: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Robot + anodal tDCSRobot + sham tDCS
Robotic-assisted gait trainingDEVICE

Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments

Also known as: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)
Robot + anodal tDCSRobot + sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
  • Hemiplegic patients due to unilateral lesion
  • Patients in chronic stage after 6 months from stroke onset
  • Patients with gait impairment (FAC \<= 4)
  • Adult (Age \>= 18)

You may not qualify if:

  • Unstable vital sign
  • History of seizure or cranial operation
  • unable to walk before stroke
  • bilateral hemispheric lesions
  • metalic implant (cardiac pacemaker, artificial cochlear, etc.)
  • severe cognitive deficit, MMSE \< 10
  • severe aphasic patient who cannot communicate at all

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Byung-Mo Oh, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 15, 2013

First Posted

September 18, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations

KR(1)